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The Central Drugs Standards Control Organisation (CDSCO) have given emergency use authorisation for an antibody-drug cocktail developed by Roche and Regeneron to treat the novel coronavirus, drug firm Roche India on Wednesday said.

"This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited," Roche India said in a statement.

The approval of antibody cocktail of Casirivimab and Imdevimab in India was based on the data filed for the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union, it added.

Drug to be used for treatment of mild to moderate cases

The antibody cocktail is to be administered for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease, the statement said.

It could significantly help these high-risk patients before their condition worsens, it added.

"With the increasing number of COVID-19 infections in India, Roche is committed to doing everything we can to minimise hospitalisations and ease pressure on healthcare systems," Roche Pharma India MD V Simpson Emmanuel said.

This is where neutralising antibody cocktails like Casirivimab and Imdevimab can play a role in the fight against COVID-19 and in treatment of high risk patients before their condition worsens, it added.

Cipla MD and Global CEO Umang Vohra said, "This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of 'Caring for Life'".

Cipla will market and distribute the product in India by leveraging its distribution strengths across the country.

The drug will be available through leading hospitals and COVID treatment centres, Roche India said.

In India, 3,780 people died of Covid-19 in the last 24 hours, the highest in a day so far, pushing the total fatalities to 2,26,188. India's Covid caseload hit 2.06 crore with over 3.82 lakh new cases as the crisis continues to crush the healthcare system.

India is second only to the US in the total number of cases reported since the beginning of the Covid-19 pandemic.

Meanwhile, Principal Scientific Advisor to Centre K VijayRaghavan on Wednesday said that the "third phase" of the COVID-19 is inevitable.

"A phase three is inevitable, given the higher levels of circulating virus but it is not clear on what time scale this phase three will occur. We should prepare for new waves," he said.

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